Gestational Diabetes Clinical Trial
Official title:
the Efficacy of Fetal Arterial and Venous Doppler Indices in Predicting Perinatal Outcome Among Diabetic Pregnant Patients
NCT number | NCT05410080 |
Other study ID # | Hany Saad |
Secondary ID | |
Status | Recruiting |
Phase | |
First received | |
Last updated | |
Start date | June 15, 2022 |
Est. completion date | October 20, 2022 |
To determine and evaluate the diagnostic performance of Doppler sonography of umbilical artery (UA), fetal middle cereberal artery (MCA), ductus venosus (VD) and umbilical vein (UV) for prediction of adverse perinatal outcome among diabetic pregnant women.
Status | Recruiting |
Enrollment | 140 |
Est. completion date | October 20, 2022 |
Est. primary completion date | September 20, 2022 |
Accepts healthy volunteers | |
Gender | Female |
Age group | 18 Years to 35 Years |
Eligibility | Inclusion Criteria: - The included women age will range between 18 and 35 years old. - They will carry a singleton healthy living fetus at a gestational age between 34 and 39 weeks (confirmed by a reliable date for the last menstrual period or/and 1st trimester ultrasound scan). - known to be diabetic in the current pregnancy (PGDM or GDM). Exclusion Criteria: - Women with other maternal medical disorders that may affect perinatal outcome rather than diabetes were excluded from the study. - women with pre-labour rupture of membrane. - antepartum hemorrhage, fetuses with congenital anomalies . - who will receive respiratory depressants (e.g., opioid analgesics) within 2 hours of delivery. |
Country | Name | City | State |
---|---|---|---|
Egypt | Cairo University | Cairo | |
Egypt | Kasr Alainy hospital (Faculty of Medicine-Cairo University) | Cairo |
Lead Sponsor | Collaborator |
---|---|
Cairo University |
Egypt,
Type | Measure | Description | Time frame | Safety issue |
---|---|---|---|---|
Primary | The diagnostic value of umbilical artery (UA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients | The diagnostic value of umbilical artery (UA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of umbilical artery RI & PI in detecting adverse perinatal outcome. |
within 24 hours before delivery | |
Primary | The diagnostic value of middle cerebral artery (MCA) Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients | The diagnostic value of middle cerebral artery (MCA) Doppler indices (RI & PI) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of middle cerebral artery RI & PI in detecting adverse perinatal outcome. |
within 24 hours before delivery | |
Secondary | The diagnostic value of cerebroplacental ratio (CPR) in predicting adverse perinatal outcome among diabetic pregnant patients. | The diagnostic value of cerebroplacental ratio (CPR) [MCA/UA PI] in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of CPR in detecting adverse perinatal outcome. |
within 24 hours before delivery | |
Secondary | The diagnostic value of ductus venosus Doppler indices in predicting adverse perinatal outcome among diabetic pregnant patients. | The diagnostic value of ductus venosus Doppler indices ( PVIV,PSV and abnormal A wave) in predicting adverse perinatal outcome among diabetic pregnant patients.
Sensitivity and specificity of ductus venosus PVIV,PSV and abnormal A wave in detecting adverse perinatal outcome. |
within 24 hours before delivery |
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